NOTICE: Applications submitted in response to this Funding
Opportunity Announcement (FOA) for Federal assistance must be submitted electronically
through Grants.gov (http://www.grants.gov)
using the SF424 Research and Related (R&R) forms and the SF424 (R&R)
Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application
guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter
called Grants.gov/Apply).

A registration process is necessary before submission and
applicants are highly encouraged to start the process at least four weeks prior
to the grant submission date. See Section IV.

Purpose.The
NCRR High-End Instrumentation Grant (HEI) program solicits applications from
groups of NIH-supported investigators to purchase a single major item of
equipment to be used for biomedical research that costs at least $750,000. The
maximum award is $2,000,000. Instruments in this category include, but are not
limited to, structural and functional imaging systems, macromolecular NMR
spectrometers, high-resolution mass spectrometers, cryoelectron microscopes and
supercomputers.

Mechanism of Support.This
Program Announcement will use the NIH S10 mechanism

Funds Available and Anticipated Number of AwardsThe
NCRR intends to commit approximately $20 million in FY2008 to fund approximately
10-15 new awards. Since the cost of the various instruments will vary, it is
anticipated that the size of awards will also vary. The total amount awarded
and the number of awards will depend on the funds available for the SIG
program.

Budget and Project Period.Awards are for one year and for
direct costs only. Cost sharing is not required.

Eligible Project
Directors/Principal Investigators (PDs/PIs): Eligible principal investigators include any technically qualified research
scientists. To be eligible to apply, three or more NIH funded investigators
(Principal Investigators of active P01, R01,
U01, R35, or R37 research grants) who will be users of the requested
instruments must be identified.

Number of Applications. There is no
limit on the number of applications an institution may submit provided the
applications are for different types of equipment.

Renewals and Resubmissions.Renewal (formerly
“competing continuation” or “Type 2”) applications are not permitted.
Applicants may submit a “resubmission” application, but such applications
must include an “Introduction” addressing the previous peer review
critique (Summary Statement).

Number of
PDs/PIs. Multiple PDs/PIs are not allowed under the S10 mechanism.

With advances in technological
development, biomedical scientists require ever more powerful tools for their
research. As new instruments with enhanced performance become available, their
importance for research increases along with the costs. Although the Shared
Instrumentation Grant Program (SIG) provides a cost-effective mechanism for
groups of NIH supported investigators to obtain commercially available
equipment costing between $100,000 and $500,000, there is a continuing need for
an NIH program that provides expensive, high-end instruments to the broad
community of basic and clinical scientists. To meet the demands of the
community, the NCRR initiated this HEI program in FY 2002 to support expensive,
high-end instruments.

Examples of key
instruments in this category include but are not limited to: Biomedical
Imagers: The boundaries of imaging technology have been extended to acquire
functional, biochemical and physiological information intact on biological
systems including humans. This has led to an increased demand for multinuclear
spectroscopy and functional magnetic resonance and PET imaging instruments.
Nuclear Magnetic Resonance Spectrometers: There is a significant demand for
increased sensitivity and resolution of high-field NMR spectrometers to
determine three-dimensional structures of large proteins and protein complexes
in extremely small samples. This need is magnified by the extended run time for
data collection at lower fields, which limits access to these instruments. Mass
Spectrometers: Instruments that combine electrospray ionization with Fourier
transform ion cyclotron resonance (FTICR) mass spectrometry are now available.
The FTICR methods provide very high resolution and accurate molecular weight
measurement to study large biopolymers and their interactions. Electron
Microscopes: The frontier of cell biology now focuses on elucidating the nature
and function of cell organelles and the role of complex protein machines. Such
studies require intermediate voltage electron microscopes with field emission
illumination for high resolution imaging of single molecules. Such microscopes
are also needed to perform computer reconstruction at the subnanometer scale
for macromolecular assemblies that are too large and complex to study by x-ray
crystallography and NMR spectroscopy. Supercomputers: Computational biologists
require computers or clusters of computers with high-performance visualization
hardware, parallel architectures, and large data storage and transfer
capabilities at increased speed. Applications for general use computer networks
will not be accepted. Applications for synchrotron equipment, with the
exception of detectors, will not be accepted.

For purpose of
eligibility, a major user group of three or more investigators must be
identified. A minimum of three major users must be Principal Investigators on
NIH peer reviewed research grants at the time of the application and award. For
purposes of this program, research grants are defined as those grants awarded
with the following activity codes: P01, R01, U01, R35, and R37.

The application
should also show a clear need for the instrumentation by projects supported by
multiple NIH peer reviewed research grants (including, but not limited to those
listed above) and demonstrate that these projects will require at least 75
percent of the total usage of the instrument. Major users can be individual
researchers, or a group of investigators within the same department or from
several departments at the applicant institution. NIH extramural awardees from
other nearby institutions may also be included.

It is expected
that most of the equipment requested in the HEI Program will be of a
specialized nature and will require a high level of technical expertise to
operate the instrument and conduct experiments. Therefore, for the requested
instrument to be used effectively and to avoid abuse of instrumentation, which
frequently occurs in an open access environment, the bulk of the research time
may have to be reserved for a few investigators. Alternatively, some type of
instruments might be accessed by the research community through collaborations
with appropriate investigators. Other types of instruments requested may not be
as dedicated and will serve a broadly diversified biomedical community. In any
case, priority for instrument use should be given to NIH-supported scientists
engaged in biomedical/behavioral research.

Each applicant institution must propose a
Principal Investigator who can assume administrative/scientific oversight
responsibility for the instrumentation requested. This person need not be an
NIH grantee but must be affiliated with the applicant institution and
registered on the eRA Commons. Multiple Principal Investigators are not allowed
under the S10 mechanism. An internal advisory committee must be named to assist
the Principal Investigator in administering the grant and overseeing the responsibility
for the instrument. The membership of this committee should be broadly
based and include members without conflicts of interest who can resolve
disputes if they arise. The Principal Investigator and the advisory
committee are responsible for the development of guidelines for:

The development of
guidelines for maximum utilization of the instrument, including time
allocation.

A detailed plan for the
day-to-day management and safe operation of the instrument.

If appropriate, a plan to
ensure that access to the instrument is limited to users whose projects
have received approval by institutional human subjects, animal welfare or
biosafety committees.

A financial plan for the
long term operation and maintenance of the instrument during the post award
period.

The relocation of the
instrument within the institution if the major user group is significantly
altered.

The Principal Investigator also will be
responsible for:

Requesting no-cost
extensions of the project period, if needed.

Submitting a Final Progress
Report, ninety days following the end of the project period, which
describes the instrument purchased, a list of all users and a description
of the value of the instrument to the investigators and to the institution
as a whole

This funding opportunity will use
the S10 (HEI) award mechanism. As an applicant, you will be solely responsible
for planning, directing, and executing the proposed project. HEI provides
support for expensive state-of-the-art instrumentation utilized in both basic
and clinical research. Applications are limited to instruments that cost at
least $750,000 per instrument or integrated instrument system. Since the nature
and scope of the instruments that may be requested will vary, it is anticipated
that the size of an award will vary also. There is no upper limit on the cost
of the instrument, but the maximum award is $2,000,000. If the amount of funds
requested does not cover the total cost of the instrument, the application
should describe the proposed source(s) of funding for the balance of the cost
of the instrument. Documentation of the availability of the remainder of
funding, signed by an appropriate institutional official, must be presented to
NCRR prior to issuance of award. Awards will be made for the direct costs only.
The program does not provide facilities and administrative (F &A) costs or
support for construction or alterations and renovations. Matching funds are not
required. However, commitment of an appropriate level of institutional support
to insure the associated infrastructure is expected (building alterations, or
renovations, post-award service contracts and technical personnel). Grants will
be awarded for a period of one year and are not renewable. Supplemental
applications will not be accepted.

Applicants proposing
purchase of an instrument that the institution is planning to lease prior to
award are urged to consult with their institutional sponsored projects office
regarding applicable NIH policy prior to executing the leasing agreement. If
the leasing agreement was executed more than one year prior to submission of
the HEI application, the applicant must provide strong justification for the
requested Federal funds. Further, the instrument must be considered
state-of-the-art at the time of submission of the HEI application. Award
adjustments may be necessary. Execution of a purchase order or agreement,
making a down payment or other formal commitment to purchase the equipment
prior to award must be in compliance with NIH policy regarding pre-award cost
authority [see NIH Grants Policy Statement (Rev.12/03), Allow ability of
Costs/Activities, Prewar (Regalement) Costs, page 94]. Non-compliance with this
policy automatically eliminates an applicant from eligibility for an award.

2.
Funds Available

Although the financial plans of the NCRR
provide support for this program, awards pursuant to this funding opportunity
are contingent upon the availability of funds and the receipt of a sufficient
number of meritorious applications.

The NCRR intends to commit
approximately $20 million in FY2008 to fund approximately 10-15 new awards. The
minimum award is $750,000; the maximum award is $2 Million. Since the cost of
the various instruments will vary, it is anticipated that the size of the award
also will vary. The total amount awarded and the number of awards will depend
on the funds available for the HEI program. Awards are for one year only. The
anticipated start date is July 1, 2008.

Section
III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application(s) if your institution/organization
has any of the following characteristics:

Under the general research
support authority of Section 301(a) (3) of the Public Health Service Act,
Shared Instrumentation Grant awards are made to public and non-profit domestic
institutions only. These institutions include health professional schools,
other academic institutions, hospitals, health departments, and research
organizations. Note that Federal institutions, foreign institutions, and
for-profit institutions are not eligible to apply. A Federal institution is
defined by the NIH as a Cabinet-level department or independent agency of the
executive branch of the Federal Government or any component organization of
such a department or agency.

To be eligible to apply,
three or more NIH funded investigators (Principal Investigators of active P01,
R01, U01, R35 or R37 research grants) who will be users of the requested
instrument must be identified.

1.B.
Eligible Individuals

Any individual with the
skills, knowledge, and resources necessary to carry out the proposed research
as the Project Director/Principal Investigator (PD/PI) is invited to work with
his/her organization to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH support.

For purpose
of eligibility, a major user group of three or more investigators must be
identified. A minimum of three major users must be Principal Investigators on
NIH peer reviewed research grants at the time of the application and award. For
purposes of this program, research grants are defined as those grants awarded
with the following activity codes: P01, R01, U01, R35, and R37.

Although the focus
of the HEI Program is on a new generation of instruments that cost over
$1,000,000 the floor for the program has been set at $750,000. Applications for
routine instruments such as mid-field NMR spectrometers and other applications
for requests totaling over $750,000 which are the result of an overestimation
of price and/or an excessive number of accessories, will be returned as not
being responsive. Identical or very similar applications may not be submitted
to the SIG Program and the HEI Program. However, a revised application based on
a previously reviewed SIG submission may be submitted to the HEI Program. In
order to submit a revised application, the investigator must have received the
summary statement from the previous review and must address the criticisms
raised in the Introduction. An institution may submit more than one
application, but the instruments requested should be substantially different.
It is anticipated that only a few grants will be awarded in a given
technological area.

Section
IV. Application and Submission Information

To download a SF424 (R&R) Application Package and
SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for
this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

The individual designated
as PD/PI on the application must also be registered in the NIH eRA Commons.

The PD/PI must hold a
PD/PI account in the Commons. Applicants should not share a Commons account for both an Authorized Organization Representative/Signing Official (AOR/SO)
role and a PD/PI role; however, if they have both a PD/PI role and an
Internet Assisted Review (IAR) role, both roles should exist under one Commons account.

This
registration/affiliation must be done by the AOR/SO or their designee who
is already registered in the Commons.

Both the PD/PI(s) and AOR/SO
need separate accounts in the NIH eRA Commons since both are authorized to view
the application image.

Note that if a PD/PI is also an NIH peer-reviewer with an
Individual DUNS and CCR registration, that particular DUNS number and CCR
registration are for the individual reviewer only. These are different than any
DUNS number and CCR registration used by an applicant organization. Individual
DUNS and CCR registration should be used only for the purposes of personal
reimbursement and should not be used on any grant applications submitted to the
Federal Government.

Several of the steps of the registration process could
take four weeks or more. Therefore, applicants should immediately check with
their business official to determine whether their organization/institution is
already registered in both Grants.gov and
the Commons. The NIH will
accept electronic applications only from organizations that have completed all
necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R)
application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package
directly attached to a specific FOA can be used. You will not be able to use
any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA),
although some of the "Attachment" files may be useable for more than
one FOA.

Prepare all applications using the SF424 (R&R)
application forms and in accordance with the SF424
(R&R) Application Guide for this FOA through Grants.gov/APPLY.

The SF424 (R&R) Application
Guide is critical to submitting a complete and accurate application to NIH.
There are fields within the SF424 (R&R) application components that,
although not marked as mandatory, are required by NIH (e.g., the
“Credential” log-in field of the “Research & Related Senior/Key Person
Profile” component must contain the PD/PI’s assigned eRA Commons User ID).
Agency-specific instructions for such fields are clearly identified in the
Application Guide. For additional
information, see “Frequently Asked Questions – Application Guide, Electronic Submission
of Grant Applications.”

The SF424 (R&R) application is comprised of data
arranged in separate components. Some components are required, others are
optional. The forms package associated with this FOA in Grants.gov/APPLYwill include all
applicable components, required and optional. A completed application in
response to this FOA will include the following components:

11. Descriptive Title of
the Applicant’s Project. Enter
the type of instrument requested.

13. Proposed
Project. Enter start date of 07/01/2008 and end date of 03/31/2009.

16. Estimated Project Funding. Enter the total Federal funds for the
requested instrument in line a. This will be the total cost since the
award period for the HEI program is one year. If the cost of the instrument
is more than $2,000,000, enter $2,000,000 on this line, since this is the
maximum award under the HEI program. In line b, enter the total cost of
the instrument from the quote. If lines a and b are not the same, explain
the difference in section 10 Equipment in the Other Project Information
component (see below). Enter zero for line c.

SF424 Research &
Related Other Project Information

1. Are Human Subjects Involved? Check
no.

2. Are Vertebrate Animals Used? Check
no.

6.Project Summary/Abstract. The Project
Summary/Abstract and Relevance componentsmust be combined as
one single document and attached in line 6.

The first and major
component of the Project Summary/Abstract is a Project Summary. It
is meant to serve as a succinct and accurate description of the proposed work
when separated from the application. State the application’s broad,
long-term objectives and specific aims, making reference to the health
relatedness of the project. Describe concisely the research design and
methods for achieving the stated goals. This section should be
informative to other persons working in the same or related fields and, insofar
as possible, should be understandable to a scientifically or technically
literate reader.

The second component of the
Project Summary/Abstract is Relevance. Using no more than two or three
sentences, describe the relevance of this research to public health. In
this section be succinct and use plain language that can be understood by a
general, lay audience.

The Project Summary/Abstract
must be no longer than 30 lines of text.

7. Project Narrative. If you are submitting an resubmission (Cover
Page Item 8) then you should include an Introduction describing the changes
that have been made in response to comments in the previous review. This
Introduction may not exceed three pages.

Divide the Project Narrative
into the following sections that follow the review criteria.

A) Justification of Need

Describe the instrument
requested. Inventory similar instruments existing at the applicant institution,
neighboring research institutions, or otherwise accessible; describe why they
are unavailable or inappropriate for the proposed research. For a new
generation instrument present the design concept, rational and development
methods in sufficient detail to allow evaluation of its technical feasibility. Provide
a clear justification why new or updated equipment, including accessories, are
needed. Include specific documentation on the current usage and downtime of
existing instruments and a realistic estimate of the projected usage for the
requested instrument. Such documentation should be expressed as hours of
use, setup time, etc., per day or week, not simply as percentage of available
time. Be specific and quantitative.

B) Technical Expertise

Describe the technical
expertise present at the institution to set up, run and maintain the
instrument. Specify who will operate the instrument, train new users, and
ensure that it is operated safely and appropriately maintained. Are there any
collaborations between disciplinary and interdisciplinary scientists for
developing the technical aspects of the instrumentation? Outline the roles of
the technical staff in training new users and in facilitating the adoption of
these state-of-the-art techniques in the users' research programs.

C) Research Projects

Give a brief description of
the major users projects. Since the projects have been previously peer
reviewed, the project descriptions should be concise and focus on the benefit
of the instrument to the research objectives of each user. Sufficient technical
detail (preliminary data and/or supplemental information) should be included
within the research plan to evaluate whether the instrument is appropriate,
would be effectively employed, and would provide advantages over other methods.
The need for special features and accessories must be justified. Individual
projects that require a specific option or upgrade (e.g., a UV laser) should
describe the specific studies that utilize this option. If possible, each user
should highlight those publications that demonstrate the user's expertise in
using the requested instrumentation. If the number of projects is large and
broadly diversified, select out a smaller representative group. For minor
users, only include a very brief (one-paragraph) summary of the research
related to the need for the instruments. Although there is no overall page
limitation, the research projects should be informative and succinct (recommend
three pages or less per major user).

Summary Table(s)

Use a table to list the names
of the users from section C, brief titles of the projects, the NIH grant
numbers and the estimated percentage of use. Make a separate table to indicate
the users needs for the requested accessories.

D) Institutional
Commitment

Explain how the requested
instrumentation will contribute to the institution's biomedical research goals.
Describe the institutional infrastructure (space, environment and utilities)
available to support the instrumentation. Indicate if the institution has any
history of making technology available and for keeping instruments in top
operating condition.

E) Administration of the
Instrument

Describe the organizational
plan for administering the grant. Include how the instrument will be utilized,
how request are made, how time will be allocated to competing research projects
and how schedules are posted. Describe a plan for managing access to the
instrument if users projects involve human subjects, animals or human of
infectious materials. How will the results obtained be disseminated broadly to enhance
scientific understanding? What are the plans for attracting new users? Include
the names and titles of members of the advisory committee to oversee its use.
Describe the role and responsibility of the advisory committee(s) in developing
policies and procedures to assure equitable use of the instrument time and
their meeting schedules.

F) Financial
Administration

Provide a financial plan for
long-term operation of the instrument. Specify how and by whom the requested
instrumentation will be operated and maintained. Pertinent data on user
charges, salaries of technical support personnel, maintenance contracts,
instrument upgrades, shop charges and other expenses, should be included.
Specify the plans for fully funding the instrument. Specify the sources and
amounts of cost sharing funds (private, state or institutional funds) and a
projection of when they will be available. Give a time frame or prospects for
delivery of the instrument. Provide documentation (separate letters signed by
appropriate institutional officials) specifically describing the institutional
commitment (in dollars) in support of the instrument. Those letters must be
scanned and uploaded in the Other Attachments section (line 11).

The entire Project
Narrative (Section A-G) must be saved as a single file and attached as item 7
in the Other Project Information component. Although there is no overall
page limit, applicants are reminded to be informative yet succinct.

9.Facilities & Other Resources. Not
applicable. Do not include an attachment here.

10. Equipment. Describe the instrument requested including
manufacturer and model number. The model chosen should be justified by
comparing its performance with other available instruments where appropriate.
Specific features and any accessories should be justified, both in this section
and in the description of research projects. Provide a detailed budget
breakdown of the main equipment and accessories requested including tax and
import duties, if applicable. An itemized quote from a vendor should be
included. The quote must be scanned and combined in a single attachment
with the equipment description as part of the item 10 upload. If human or
infectious materials, which could create a potential biohazard, are to be
analyzed, funds for accessory containment equipment for the instrument may be
requested in the budget. In this case, a signed letter from the institutional
biosafety committee stating that they have reviewed the proposed containment
plan and that the plan adheres to documented biosafety regulations is required
in the application. This letter must be scanned and uploaded in the Other
Attachments section (line 11).

11. Other
Attachments. Both letters from
appropriate institutional officials (mentioned in F Financial Administration)
and letters from the biosafety committee (line 10), if needed, should be
attached here. After the application has been submitted, the
assigned SRA must be contacted concerning submission of supplemental
information.

Senior/Key Person
Profile(s) Component

Include profiles for the
Principal Investigator, the Major Users, and for the technical person(s)
responsible for the maintenance and operation of the instrument. For the
Major Users, select “Other” under Project Role. Then complete the Other
Project Role Category by inserting Major User. For technical person(s),
select “Technician” for Project Role field. Follow the instructions in
the Application Guide for Additional Senior/Key Person Profile(s) if there are
more than 8 major users.

11. Current and Pending Support. This FOA requires
current and pending support for the Principal Investigator, each major user
and/or technician at the time of application submission. Follow the
format provided in Other Support section of the Application Guide (Part III.
Section I.H. Other Support).

Prospective applicants are asked
to submit a letter of intent that includes the following information:

Descriptive
title of proposed research.

Name,
address, and telephone number of the PD/PI.

Names
of other key personnel.

Participating
institutions.

Number
and title of this funding opportunity.

Although a letter of intent is
not required, is not binding, and does not enter into the review of a
subsequent application, the information that it contains allows IC staff to
estimate the potential review workload and plan the review.

To submit an application in response to this FOA, applicants should access this
FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted
electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C.
Application Processing

Applications may be submitted on or after
the opening date and must be successfully received by Grants.gov no
later than 5:00 p.m. local time (of the
applicant institution/organization) on the
application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt
date(s) and time, the application may be delayed in the review process or not
reviewed.

Once an application package has been successfully
submitted through Grants.gov, any errors have been addressed, and the assembled
application has been created in the eRA Commons, the PD/PI and the Authorized
Organization Representative/Signing Official (AOR/SO) have two business days to
view the application image.

If everything is acceptable, no
further action is necessary. The application will automatically move forward
for processing by the Division of Receipt and Referral, Center for Scientific
Review, NIH, after two business days.

Prior to the submission deadline,
the AOR/SO can “Reject” the assembled application and submit a
changed/corrected application within the two-day viewing window. This option
should be used if the AOR/SO determines that warnings should be addressed.
Reminder: warnings do not stop further application processing. If an
application submission results in warnings (but no errors) it will
automatically move forward after two business days if no action is taken.
Please remember that some warnings may not be applicable or may need to be
addressed after application submission.

If the two-day window falls after
the submission deadline, the AOR/SO will have the option to “Reject” the
application if, due to an eRA Commons or Grants.gov system issue, the application
does not correctly reflect the submitted application package (e.g., some part
of the application was lost or didn’t transfer correctly during the submission
process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the
system error, document the issue, and determine the best course of action. NIH
will not penalize the applicant for an eRA Commons or Grants.gov system issue.

If the AOR/SO chooses to “Reject”
the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted,
but it will be subject to the NIH late
policy guidelines and may not be accepted. The reason for this delay should
be explained in the cover letter attachment.

Both the AOR/SO and PD/PI will
receive e-mail notifications when the application is rejected or the
application automatically moves forward in the process after two days.

Upon receipt, applications will
be evaluated for completeness by the Center for Scientific Review, NIH.
Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of
applications from Grants.gov and the Commons. Information related to the
assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the
responsibility of the applicant to check periodically on their application
status in the Commons.

The NIH will not accept any
application in response to this FOA that is essentially the same as one
currently pending initial merit review unless the applicant withdraws the
pending application. The NIH will not accept any application that is
essentially the same as one already reviewed. This does not preclude the
submission of an application already reviewed with substantial changes, but
such application must include an “Introduction” addressing the previous
critique. Note such an application is considered a "resubmission" for
the SF424 (R&R).

All NIH awards are subject to the terms and
conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at
its own risk and without NIH prior approval, incur obligations and expenditures
to cover costs up to 90 days before the beginning date of the initial budget
period of a new or competing renewal award if such costs: are necessary to conduct the project,
and would be allowable under the grant, if awarded, without NIH prior approval.
If specific expenditures would otherwise require prior approval, the grantee
must obtain NIH approval before incurring the cost. NIH prior approval is
required for any costs to be incurred more than 90 days before the beginning
date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See the NIH Grants
Policy Statement.

6. Other Submission
Requirements

PD/PI
Credential (e.g., Agency Login)

The NIH requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential”
log-in field of the “Research & Related Senior/Key Person Profile”
component. The applicant organization must include its DUNS number in its
Organization Profile in the eRA Commons. This DUNS number must match the DUNS
number provided at CCR registration with Grants.gov. For additional
information, see “Registration FAQs – Important Tips -- Electronic Submission
of Grant Applications.”

Organizational DUNS

The applicant organization must
include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with
Grants.gov. For additional information, see “Frequently Asked Questions –
Application Guide, Electronic
Submission of Grant Applications.”

Warning: Please be sure
that you observe the direct cost, project period, and page number limitations
specified above for this FOA. Application processing may be delayed or the
application may be rejected if it does not comply with these requirements.

Do
not use the Appendix to circumvent the page limitations of the Research Plan
component. An application that does not observe the required page limitations
may be delayed in the review process.

Note: While each section of the
PHS398 Research Plan component needs to be uploaded separately as a PDF
attachment, applicants are encouraged to construct the Research Plan component
as a single document, separating sections into distinct PDF attachments just
before uploading the files. This approach will enable applicants to monitor
better formatting requirements such as page limits. All attachments must be
provided to NIH in PDF format, filenames must be included with no spaces or
special characters, and a .pdf extension must be used.

Plan for Sharing Research Data

Not applicable.

Sharing Research Resources

Not applicable.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process.

2. Review and
Selection Process

Applications that are complete will be
evaluated for scientific and technical merit by specially convened initial
review groups of the CSR in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:

Undergo a selection process
in which only those applications deemed to have the highest scientific
merit, generally the top half of applications under review, will be
discussed and assigned a priority score

Receive a written critique

Receive a second level
review by the National Advisory Research Resources Council (NARRC).

In making funding decisions, the NCRR will
give consideration to the following:

scientific merit of the
proposed project as determined by peer review

availability of funds

relevance of program
priorities

program balance among
various types of instruments supported and geographic distribution of
awards

Review Criteria:

The review committee will
consider the following criteria:

Justification
of Need:

Is the need for
the instrument clearly and adequately justified? Is the equipment essential and
appropriate? Will the instrument requested have a significant impact on biomedical/behavioral
research and contribute to the advancement of human health?

Technical
Expertise:

Does the
institution have the high-level technical expertise and access to the necessary
infrastructure to make effective use of the requested equipment? How well
qualified are the participating investigators to operate and maintain the
instrument, conduct the projects, and evaluate the research results? How will
new users be trained? Are there collaborations in place between disciplinary and
interdisciplinary scientists? How will biosafety procedures be implemented?

Research
Projects:

Will research
with the requested instrument advance the knowledge and understanding of the
proposed projects? How would the research project of each major user be
enhanced? Will the results be disseminated broadly to enhance scientific and
technological understanding? Are there appropriate plans in place for record
keeping and bioinformatics?

Institutional Commitment:

What is the evidence of
institutional commitment to support the instrument? Is institutional
infrastructure (technical support, space, environment and utilities) available
to support the instrument? Is there an institutional track record for making
technology available?

Administration:

Is the plan for the management
and maintenance of the requested instrument appropriate? Are there plans for
maximizing the effectiveness of the investment in instrumentation? Is there an
advisory committee for oversight of the instrument including sharing
arrangements? Is the membership of the advisory committee broadly based to
oversee the use of the instrument for a wide range of biomedical investigators?
How will research time be allocated among the projects? Are the sharing
arrangements equitable? If needed, are the policies to manage human subject,
animal or biohazardous materials projects adequate?

Financial Plan:

Is the financial plan for
fully funding the purchase and long-term operation and maintenance of the
instrument reasonable? Is there appropriate documentation (letters from
institutional officials)?

2.A.
Additional Review Criteria:

Resubmission Applications
(formerly “revised/amended” applications): Are the responses to comments
from the previous scientific review group adequate? Are the improvements in
the resubmission application appropriate?

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the
appropriateness of the requested period of support in relation to the proposed
research may be assessed by the reviewers. The priority score should not be
affected by the evaluation of the budget.

2.C.
Sharing Research Data

Not applicable.

2.D.
Sharing Research Resources

Not applicable.

3.
Anticipated Announcement and Award Dates

Not applicable.

Section
VI. Award Administration Information

1.
Award Notices

After the peer review of the application is completed, the PD/PI will be able
to access his/her Summary Statement (written critique) via the NIH eRA Commons.

Just-in-time information will not be requested for S10
applications.

A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via email
notification from the awarding component to the grantee business official.

Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Section
IV.5., “Funding Restrictions.”

Ninety days following the end of the project
period, a Final Progress report is required that describes the instrument
purchased, and a list of all users and description of the value of the
instrument to the investigators and to the institution as a whole. The
Final Progress Report instructions are available at http://www.ncrr.nih.gov/biotech/btforms.asp.

Section
VII. Agency Contacts

We encourage your inquiries
concerning this funding opportunity and welcome the opportunity to answer
questions from potential applicants. Inquiries may fall into three areas:
scientific/research, peer review, and financial or grants management issues:

NIH Public Access Policy:NIH-funded investigators are requested to submit to
the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at
PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts
resulting from 1) currently funded NIH research projects or 2) previously
supported NIH research projects if they are accepted for publication on or
after May 2, 2005. The NIH Public Access Policy applies to all research grant
and career development award mechanisms, cooperative agreements, contracts,
Institutional and Individual Ruth L. Kirschstein National Research Service
Awards, as well as NIH intramural research studies. The Policy applies to
peer-reviewed, original research publications that have been supported in whole
or in part with direct costs from NIH, but it does not apply to book chapters,
editorials, reviews, or conference proceedings. Publications resulting from
non-NIH-supported research projects should not be submitted.

For more information about the Policy or the
submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/
and view the Policy or other Resources and Tools, including the Authors' Manual.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for
NIH funding must be self-contained within specified page limitations. For
publications listed in the appendix and/or Progress report, Internet addresses
(URLs) or PubMed Central (PMC) submission identification numbers must be used
for publicly accessible on-line journal articles. Publicly accessible
on-line journal articles or PMC articles/manuscripts accepted for publication
that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference
in either the Bibliography & References Cited section, the Progress Report
Publication List section, or the Biographical Sketch section of the NIH grant
application. A URL or PMC submission identification number citation may be
repeated in each of these sections as appropriate. There is no limit to the
number of URLs or PMC submission identification numbers that can be cited.

Healthy People 2010:The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting
priority areas. This FOA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:This program is described
in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review. Awards are made under the
authorization of Sections 301 and 405 of the Public Health Service Act as
amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and
45 CFR Parts 74 and 92. All awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants
Policy Statement.

The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent with
the PHS mission to protect and advance the physical and mental health of the
American people.